Thursday, February 25, 2016

White House One Year Anniversary Summit on Precision Medicine (Feb 25, 2016)

On February 25, the White House streamed live a one year anniversary summit for the Precision Medicine Initiative.   Youtube website here (initially streamed live;  also the archive link.  President enters at 1h50m).

I've provided an open access, 40 page transcript (16,000 words), in the cloud, here.  In addition, I've put the two hour conference in the cloud as a downloadable 160 mb mp3 file, here.

For pre-publicity press on the event at Morning Consult, here.  At Washington Post, here.  At "STAT," here and here.  Fast Company here.  New York Times here.  Beckers Hospital Review here. Genomeweb here.  More after the break.

There is progress toward the NIH goal of 1M genomic health volunteers by 2019, and a partnership with Verily (formerly Google Life Sciences, here) is enabling this work, collaborating with Vanderbilt.  (However, Francis Collins promised only 79,000 genomes by year's end.)  The VA has a similar genomic initiative, as do other countries including England..

A cloud-based pediatrics genomics platform was announced (here), including key collaborators Childrens Hospital of Philadelphia and Seven Bridges, a virtual genomics startup that just raised $45M (here).  Also aligned to the conference and pediatric oncology, Foundation Medicine announced the "first public release of broad pediatric data from FoundationCore...for pediatric cancers" (here).

HealthcareITNews summarizes: "Cerner, IBM, Epic, Verily sign on to Precision Medicine Initiative" (here).  Intel is in on the story as well (here).  As much as it is about "genetic sequencing" and "right drug, right patient," the PMI is heavily dependent on next generation informatics as well.  For more on the increasingly identifiable field of digital health and genomics, see my recent white paper (here).

As seen in subscription coverage at Gray Sheet (here), the President states that the historical regulatory division between drugs and devices was outdated.   Quoting Obama (see video circa 2h27m-2h30m), "The FDA traditionally has thought about protecting the public health in terms of, these are medical devices and these are drugs, and there are certain categories, and there are certain protocols that we go through," the president said. "When it comes to gathering data, disseminating data, making sure it’s accurate and valid, figuring out how it’s communicated to the patient or the individual who’s interested in it – sometimes we’re fitting square pegs into round holes [2h29m30s], and we may have to re-conceptualize how we think about this to open up this space....One of the charges I've given to all of the federal agencies working together on this is looking at the regulatory framework we have that was designed for another era of medicine and making sure we update it. And that's where I think the work that we do with Congress can be very important here and there's good bipartisan support for how we think about this."  This sounds like support for legislation, in that the division of drug and device regulatory law is embedded in different statutes.  "There's good bipartisan support for how we think about this...and we have a new FDA commissioner."

Concurrent with the Precision Medicine event, HHS released guidance that "encourages that patients should receive copies of health information free of charge under HIPAA." article here, HHS new webpage here (top half info, bottom half FAQs), and current 45 CFR 164.524 guidance law, here.   The "encouragement" is a little confusing since the law clearly specifies that reasonable fees may be charged, while an online webpage at HHS states that "covered entities should of charge."  HHS also notes that it monitors PHI fees and could revise the law if necessary.

As a Senator, Obama introduced the "Genomics and Personalized Medicine Act of 2006" - S.3822 of 2006.  News article here, text of the GPMA still online, here.

Just two days after the White House summit, Vice President Biden visited UCSF and discussed the Cancer Moonshot Initiative.  UCSF's article, here; includes audio (which begins at 1h10m on the weblink provided then runs about 90 minutes.)